Natural Medicine Advisory Bulletin 13: Peaking in July

July 12th: NMAB Combined Subcommittee MeetingThe July 12th meeting of the combined subcommittee began with DORA Program Director Lorey Bratten providing updates on behalf of both DORA and DOR. Director Bratten noted DOR’s upcoming local government roundtable and July 25th final rulemaking hearing. Dr. Sue Sisley raised concerns about DOR’s current limit of one kilogram for cultivators, asking Director Bratten to ensure the NMAB has an opportunity to discuss the limit at the July 19th meeting of the Board.Dr. Bradley Conner made a point of sharing his dissatisfaction with the fact that DOR has not given absolute deference to NMAB recommendations in some draft rules. According to Dr. Conner, he has expressed his displeasure at DOR’s receptiveness to public feedback to Director Bratten. At least one other member expressed a similar feeling, despite frequently acknowledging the advisory nature of the Board in the past. The sentiment that the members of an advisory board, who often have less expertise than public stakeholders and regulators, should have the absolute and final say on a subject, could be considered offensive to the process of public engagement that voters approved with the Natural Medicine Health Act.While awaiting a guest speaker’s arrival, the subcommittee engaged in open-ended discussion. Dr. Tina Gonzales raised the subject of a lineage-based accelerated licensure pathway. The suggestion, which did not make it into the first round of rules, was originally put forth by the Indigenous and Religious Use and Outreach subcommittee. Dr. Gonzales would like regulators to re-examine the suggestion and sought clarification on whether the working group or the combined subcommittee would be a more appropriate place to continue that conversation. Director Bratten indicated that the subcommittee would likely be more appropriate, as the focus of the working group is somewhat different, though the perspective of the group could be helpful for the subcommittee. Subcommittee members universally supported engaging with the working group, preferably as a whole, rather than a single representative speaking on behalf of the group. Director Bratten and the Attorney General’s office will explore the formal requirements for bringing the working group and subcommittee together. Director Bratten also reminded the subcommittee of the current accelerated licensure pathway for legacy healers, stating that DORA intends to consult with the board in coming months to develop guidance documents for approving legacy healers.Dr. Sue Sisley directed two questions to the representative from the Attorney General’s office. First, Dr. Sisley asked for an update on a months-old request for the state to formally request a memo from the US Attorney’s office. The Attorney General’s office did not have an update on this item, but stated they would follow up on it.Dr. Sisley also wanted to know the next steps for the Board’s recent legislative recommendation to the state legislature could be moved forward. Discussion identified two possible options. First, a legislator could introduce the recommendations as a bill. As the Board is not permitted to engage directly with the legislature, the crucial question is how the recommendation can get in front of potential sponsors. An alternative pathway is to go through the Governor’s office, by way of the Special Advisor on Natural Medicine. Director Bratten offered to replay the concerns to the Special Advisor.The primary agenda item consisted of a presentation and discussion with guest Nathan Howard. Mr. Howard is a founding member of the Sheri Eckert Foundation. Named for one of the co-creators of Oregon’s Measure 109, the Foundation is a 501c3 organization with a mission “to ensure that Oregon’s evolving psychedelic ecosystem is accessible to participants from diverse backgrounds, financial means, and geographies around the state and country.” Mr. Howard spoke about the foundation’s primary initiative, Psilocybin Access Fund (“PAF”), as well as several complementary initiatives. The foundation has already provided $300,000 to fund the training of 75 facilitators in Oregon. The foundation’s current initiative focuses on funding psilocybin services, and seeks to raise and distribute $1 million in grants to historically underserved populations. In tandem, the foundation is validating the benefits and safety of psilocybin therapy through its Psilocybin Therapy Insurance Initiative. Through a partnership with OPEN, the initiative collects voluntary participant outcome data, with the goal of providing evidence to induce insurance payors to cover psilocybin services. Mr. Howard also provided a firsthand look into the overall health of the Psilocybin Services program in Oregon. According to Mr. Howard, the market is trending towards group administration, which provides significant cost and resource advantages. Innertrek, a Psilocybin Service Center Mr. Howard is affiliated with, charges around $1200 per person for a group administration session. By Mr. Howard’s account, this works out to less than half of the cost of cognitive behavioral therapy per hour.Subcommittee members then engaged in a wide-ranging conversation with Mr. Howard.  First, subcommittee chair Dr. Brad Conner requested details on the mechanics of the PAF, seeking to understand how Colorado might follow suit. As a 501c3, the PAF cannot use funds to pay for psilocybin directly. Instead, the Fund pays facilitators for services provided, while coordinating delivery of donated psilocybin Funding is provided both by large institutional donors, as well as smaller donors, often psilocybin business, through social equity plans.Mr. Howard provided his perspective on recent media coverage claiming that Oregon’s program is struggling. According to Mr. Howard, while some of the concerns have merit, media reports are largely overblown. In his view, the market is still finding an equilibrium, with 2024 being the first year the program has been fully operational. Discussing opportunities for improvement in Oregon, Mr. Howard identified the state’s single-license framework as a significant issue. Without a Clinical Facilitator license to assure higher levels of care, other professionals are reluctant to refer their clients to psilocybin services. Thankfully, Colorado’s framework already addresses the issue by providing for Clinical Facilitator licenses.When asked what is stopping insurance from covering psilocybin service in Oregon, Mr. Howard pointed to a lack of data. According to Mr. Howard, insurance companies could choose to cover at least the services portion of psilocybin services at any time, if they saw value in doing so. Interestingly, Mr. Howard shared that, while outside of the single, required preparation and integration sessions, some facilitators are billing additional preparation and integration sessions to insurance as therapy sessions.Dr. Sisley asked about Adverse Event reporting in Oregon, a recent hot topic in Colorado. According to Mr. Howard, there is no official state-level data for adverse events, though he mentioned the Healing Advocacy Fund has been researching adverse events at the grassroots level. Anecdotally, Mr. Howard reported hearing of intense trips, which may not be considered “adverse events” in other cultures, but are labeled as adverse events from the western medical viewpoint. Mr. Howard reported hearing of  individuals attempting to physically leave a service center, as well as complaints against facilitators for not intervening in these intense experiences, despite non-directiveness being agreed upon by the client and facilitator. Mr. Howard identified several factors he believes contribute to these reports. First, there is a general lack of knowledge in both clients and many facilitators as to how intense a certain dose of psilocybin can be. Second, some training programs fail are not discerning enough in who they accept, or diligent enough in their training, leading to facilitators providing doses which they have never taken themselves. Additionally, Oregon does not require a safety screen of any kind. Combined, these factors can result in inexperienced facilitators providing doses they don’t fully understand to clients that should not be receiving them. The solution, in Mr. Howard’s view is to create a culture that values safety, even where regulations don’t require it. Luckily, Colorado has already taken several cues from Oregon, requiring safety screens for participants, as well as ongoing consultation for new facilitators to ensure they are supported as they gain experience.As part of the broader discussion around adverse events, Dr. Sisely asked whether Mr. Howard had heard reports of sexual misconduct by facilitators. He personally had not, however discussion turned to Colorado’s complaint procedures and reporting. Director Bratten indicated that disciplinary actions taken against a licensee are made public only after a disciplinary board finding. For conduct that does not rise to the level of disciplinary action, regulators may choose to issue a Confidential Letter of Concern, which is a non-public method of resolving complaints. This system was lauded by Mr. Howard has a significant improvement over Oregon’s.Skippy Upton-Mesirow wanted to know the most significant cost drivers of Psilocybin Services, and where Mr. Howard saw the biggest potential for cost savings. Citing facilitator time as the most significant cost, Mr. Howard felt that group administrations and multiple-day retreats offer the most significant cost reductions. Speaking about current rules regarding group size and facilitator ratios in Oregon, Mr. Howard felt that the rules were working adequately, though he would like more flexibility over time. He noted that in some regards, starting with rigid rules, which are then revised to be more flexible, can be advantageous when first developing a collective baseline understanding of an unfamiliar subject such as psilocybin services. Mr. Howard shared a report of regulated microdosing being used in groups for activities such as community building and meditation, and spoke positively about Oregon’s allowance for group and remote preparation and integration sessions.Mr. Mesirow noted that, if secondary preparation and integration sessions are able to be billed to insurance as therapy, demand may be higher for Clinical Facilitators than initially anticipated. Mr. Mesirow also inquired about the costs of 1:1 sessions. In Oregon, on-on-one administration ranges from $800-$3000, with corresponding variation in amount of preparation work included and advanced qualifications of the facilitator. Discussion demographics, Mr. Howard reported that most clients receiving psilocybin services are from out of state, while all facilitators are currently Oregon residents. Finally, Mr. Howard suggested partnering with local institutions to fund the Board’s desired Participant Outcome Database.Dr. Sophia Chavez voiced support for group administration and emphasized the need to support communities engaging in microdosing, specifically by finding ways to document benefits communities of color are experiencing. Dr. Tina Gonzales inquired about the specific data points collected in Oregon, hoping to learn where Colorado could improve over Oregon to demonstrate positive outcomes. Without getting into specifics, Mr. Howard explained that the data collected under Oregon’s SB-303 mandate is basic quantitative data about the program itself. To bridge the gap, the Psilocybin Therapy Insurance Initiative collects data which is qualitative in nature in hopes to better understand how outcomes related to an individual’s experience, history, and personal circumstances.Closing out the discussion, Mr. Howard thanked subcommittee William Dunn for his services as a paramedic, noting a first responder-centric group administration initiative in Oregon and encouraging Colorado to consider a similar program. Before Mr. Howard departed, Dr. Clarissa Pinkola-Estes asked that Mr. Howard return to speak about the specifics of the Innertrek training program.Following the conversation with Mr. Howard, the subcommittee was set to discuss a payment plan option for facilitator training programs. Unfortunately, the subject which NMAB chair Lundy had passionately advocated for, was dismissed quickly. In doing so, Dr. Conner alluded to a conversation with Director Bratten indicating that a payment plan would not be feasible. Instead, Director Bratten shared that training program applications were exceeding expectations, with at least five applications having been submitted at the time of the meeting.  While she was not able to give a specific figure, Director Bratten stated that she expects facilitator license fees to be less than the initial estimate, which was around $3,000. This would put the total cost of facilitator licensure at $10-$12k for a training program and license fee. Apparently satisfied with the current state of affairs, Dr. Conner suggested revisiting the topic at a later date to ensure there is equity and diversity in training programs. Dr. Sophia Chavez suggested that the state develop a program to assist programs in getting approved. Director Bratten reminded the group of the legacy healer accelerated licensure pathway and DPO’s general disposition of not denying licenses.For the final segment of the meeting, Director Bratten walked the subcommittee through DORA’s complete rules related to the practice of facilitation. Ms. Bratten explained any divergence from initial Board recommendations, such as where public feedback, Colorado law, or practicality required additions or modifications. Director Bratten emphasized that the Department’s rules adhered to the Board’ recommendations as closely as possible, while noting that DORA and the Board may need to reexamine recommendations and rules related to supervised practice. According to Director Bratten, feedback has indicated that current supervised practice rules will be difficult to satisfy in the early stages of the program. Ms. Bratten requested the subcommittee’s assistance in developing documents, such as informed consent and safety screening documents, that the Department will provide. Finally, Director Bratten Noted that, although rules currently require facilitators to collect participant data, collection and storage mechanisms for the information have yet to be determined.



Source link